Nonnarcotic analgesics:

Indications for: ANJESO

Moderate to severe pain, alone or in combination with non-NSAID analgesics.

Limitations of Use:

Not recommended for use when rapid onset of analgesia is required.

Adult Dosage:

Use for shortest duration. Individualize. Administer by IV bolus inj over 15secs. 30mg once daily.

Children Dosage:

Not established.

ANJESO Contraindications:

Aspirin allergy. Coronary artery bypass graft surgery. Moderate to severe renal insufficiency at risk for renal failure due to volume depletion.

Boxed Warning:

Risk of serious cardiovascular and gastrointestinal events.

ANJESO Warnings/Precautions:

Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe HF, advanced renal disease; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Advanced liver disease and/or coagulopathy. Discontinue if signs/symptoms of liver disease develop, or if systemic manifestations (eg, eosinophilia, rash) occur. Hypertension; monitor BP closely. Dehydration. Hypovolemia. Hyperkalemia. Pre-existing asthma. Discontinue at 1st sign of rash or any other hypersensitivity. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, and renal function in long-term therapy. May mask signs of infection or fever. Severe hepatic impairment: monitor. Moderate to severe renal impairment: not recommended. CYP2C9 poor metabolizers. Elderly. Debilitated. Women with infertility: not recommended. Labor & delivery. Pregnancy (≥30 weeks gestation; avoid). Nursing mothers.

ANJESO Classification:

NSAID (oxicam).

ANJESO Interactions:

Avoid concomitant aspirin (at analgesic doses), other NSAIDs, or salicylates (eg, diflunisal, salsalate). Increased risk of GI bleed with anticoagulants (eg, warfarin), antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize or increase risk of acute renal failure (esp. in elderly, volume-depleted, or have renal impairment) with ACE inhibitors, ARBs, β-blockers, diuretics; monitor. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. May be potentiated by CYP2C9 inhibitors (eg, amiodarone, fluconazole, sulphaphenazole); monitor and consider dose reduction.

Adverse Reactions:

Constipation, increased GGT, anemia; elevated ALT/AST, cardiovascular events, GI bleed/ulcer, edema, hyperkalemia, anaphylactic reactions, rash, hepatotoxicity, renal papillary necrosis, acute renal failure.

Metabolism:

Hepatic (primarily CYP2C9). ~99.4% protein bound.

Drug Elimination:

Fecal, renal. Half-life: ~24 hours.

Generic Drug Availability:

NO

How Supplied:

Single-dose vial—1